FDA
Analysts called the approval a much-needed win for Novo Nordisk, but warned that the company could struggle to grow sales once rival drugs come to market.
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Representatives of companies including AbbVie, Eli Lilly, Johnson & Johnson and Merck have voiced concerns about the FDA’s approach to pre-approval inspections.
With notable therapies from Biogen, Sarepta and MacroGenics failing to show efficacy in pivotal or confirmatory trials, experts question the use of biomarker evidence for approval while one former regulator insists that a “failed trial is not a failed drug.”
Coming up in the back half of December, the FDA will issue a verdict on Vanda Pharmaceuticals’ gastroparesis drug tradipitant, which it rejected last September, triggering a very public dispute with the company.
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The drug makers have until February 28, 2022 to review their findings and analytical processes for the drug they are developing to treat relapsed and/or refractory multiple myeloma.
The decision made VUITY the very first and only eye drop to be approved for the Presbyopia treatment. Follow the article to know aspects of this new treatment.
Scemblix is the first-in-class FDA-approved treatment for adult patients diagnosed with Philadelphia chromosome-positive chronic myeloid leukemia.
The U.S. Food and Drug Administration granted Emergency Use Authorization (EUA) for the Pfizer-BioNTech vaccine for children ages 5 to 11.
Yet another busy week for clinical trial news. Here’s a look.
Paris-based Sanofi reported its third-quarter finances, with most of its categories showing strong growth. However, not everything was rosy
Emergent BioSolutions, the manufacturer responsible for the doses in question, is reportedly just waiting for the U.S. FDA’s signal to start shipping the vaccines.
The letter was related to a 2021 FDA inspection connected to Sesen’s Biologics License Application for Vicineum. Read more about this sesen bio news here.
A large number of people were waiting for the breast cancer vaccine. Now, at present, the world has witnessed the first potential vaccine. Let’s take a look at it.
The U.S. Food and Drug Administration posted analyses of the Pfizer-BioNTech COVID-19 vaccine in children ages 5 to 11 years old ahead of Tuesday’s vaccines advisory committee meeting.